MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 6126120000

Device Problem Biocompatibility (2886)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Eight events were reported for this quarter.Three devices were available for evaluation but have not yet been received.Five devices were received for evaluation.Five events were confirmed during testing.Two devices were found to be fractured.One device was found to have missing components.Two devices were found to have a swollen component.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.

Event Description

This report summarizes 8 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Six events had no patient involvement; no patient impact.One event had no patient involvement; no patient impact.One event had no information available from the facility regarding patient involvement or patient impact.

Manufacturer Narrative

This mdr report is part of the malfunction summary reporting program, exemption number e2015055.    supplemental rationale corrected data: 1 previously reported event is included in this follow-up record.Product return status 1 device was not available to stryker for evaluation.  additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.Device not received for evaluation.

Event Description

This report summarizes 8 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.6 events had no patient involvement; no patient impact.1 event had no patient involvement; no patient impact.1 event had no information available from the facility regarding patient involvement or patient impact.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7467032
• MDR Text Key: 107222843
• Report Number: 0001811755-2018-00938
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Number of Events Reported: 8
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6126120000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1